Head of Regulatory Science, Africa & Middle East, at Pfizer with 25 years’ experience in Regulatory Affairs, External Affairs, and Marketing, supporting various healthcare categories. Pharmacist by education, licensed in UAE, Jordan, and Canada. Was appointed recently as Chair for PhRMA Middle East & Africa Regulatory Working Group.

Susanne Ausborn has more than 20 years of experience in technical regulatory affairs and regulatory policy, being currently Global Head International Regulatory Policy in Roche. M.Sci. in Analytical Chemistry and PhD in Biophysical Chemistry, Susanne is a strong advocate for global convergence of regulatory requirements and has been engaged in many international conferences, workshops and meetings with regulators from various emerging markets around the world over the last decade. Currently, she is the Vice Chair of the EFPIA IREG, member of EFPIA Middle East network and several IFPMA expert groups.

20 years working in pharmacovigilance, of which 12 have been as a director of pharmacovigilance for the affiliates at MSD. In his current role, Sean provides pharmacovigilance support to primarily the Eastern Europe, Middle East and Africa regions. Sean supports the local offices during inspections, in the development of local PSMF’s at MSD, which are legislatively required or requested pre-inspection. Responsible for Pharmacovigilance activities such as PV Intelligence and Operational activities within the International PV organization. Sean is a chairperson of two EFPIA PV working groups, (Africa and the Middle East). 

Sérgio works with different IFPMA regulatory workstreams in the development of technical policy documents and implementation of related advocacy activities for regulatory system strengthening, manufacturing quality, and regulatory reliance. He also spearheaded IFPMA’s contribution toward the establishment of the Fight the Fakes Alliance. Before joining IFPMA, Sérgio worked on late-stage drug formulation and development, and as a community pharmacist in Portugal. Sérgio holds a Diploma in Advanced Studies in Management of Clinical Trials from the University of Geneva and a Master in Pharmaceutical Sciences from the University of Coimbra, Portugal.

Nevena Miletic is a pharmacist, with postgraduate studies in parmacoeconomics, Reg Affairs and QA, with more than 18 years of experience in pharma industry. Currently she works in Global Regulatory Policy at F. Hoffmann-La Roche and for the last five years, she is co-chairing IFPMA Africa Regulatory Network and CPP Network. She is also a member of IFPMA Regulatory Science and Africa Engagement Committees, DIA MEA Advisory Board, EFPIA ERAO PI WG, IATF etc., being involved in numerous projects with regulators and cross-industry collaborative platforms (e.g. Pre-ICDRA, ICDRA, IMI, SCoMRA etc.). Nevena is a strong advocate for regulatory convergence and harmonisation, with main interest in innovative approaches in drug development and review.

Myriam Sedrati serves as Regulatory Affairs Director for North West Africa and Responsible Pharmacist at MSD Morocco. She spent 23 years of experience at the pharmaceutical industry in Europe, Middle East Africa region in 3 different pharmaceutical companies. Her professional career spans a number of roles in quality assurance, manufacturing operations, regulatory Affairs, market access in the pharmaceutical sector. She is also a member of Africa Regulatory Network in IFPMA (International Federation of Pharmaceutical Manufacturers & Associations). Myriam has a Doctorate in Pharmacy from University René Descartes Paris V - France.

Rachida is Director at the Centre Anti Poison et de Pharmacovigilance du Maroc, Ministry of Health Rabat Morocco. She is also Clinical Pharmacology Professor at the University of Pharmacy and Medicine, Rabat, Morocco. Rachida is also Director at Morocco WHO Collaborating Centre for Strengthening Pharmacovigilance Practices, Rabat and supports WHO with normative functions, pharmacovigilance systems and centres, patient safety in francophone, eastern Mediterranean and Arabic countries. She has Medical Doctor degree from Faculté de Medecine et de Pharmacie Rabat Morocco and a master in Fundamental and Clinical pharmacology from Faculté de Medecine Montpellier France.

Previously served as Senior Vice President and Managing Director for DIA Europe, Middle East, and Africa (EMEA) in addition to corporate international public affairs and as consultant for Amgen, Merck KGaA, and Biogen, working across market access, government affairs, public affairs, health policy, corporate communications, and patient advocacy to bring medicines to patients. Mr. Bols has held board positions for Europabio, the European Confederation of Pharmaceutical Entrepreneurs, and other associations, and chaired various regulatory and access working groups within the European Federation of Pharmaceutical Industries and Associations. Mr. Bols earned his post-graduate degree in European Law from the University of Amsterdam.

Dr Samvel Azatyan is a Paediatrician with a PhD in clinical pharmacology and medical products regulation. Over his more than 24 years at WHO, he has had a wide range of leadership roles associated with the regulation of medical products, including supporting regulatory collaboration, convergence and harmonization, as well as regulatory capacity building and facilitation of products introduction in the countries. Dr Azatyan has also led various projects aiming at development of national regulatory systems, as well as the development and implementation of the concept of reliance in regulation of medical products. Dr Azatyan is currently leading the Regulatory Convergence and Networks Team at the WHO's Headquarters in Geneva, Switzerland.

Dr Kang joined WHO HQ in January 2009 and has been in charge of development/implementation of WHO guidelines for regulatory evaluation of biologicals, particularly biotherapeutics including biosimilars. Prior to joining WHO, Dr Kang was a scientific officer for twelve years at Korea Ministry of Food and Drug Safety who was responsible for reviewing license applications, quality control, and inspection of biological products. In 2004, she worked on the project to develop HCV DNA vaccine at the Vaccine and Infectious Disease Organization-International Vaccine Center in the University of Saskatchewan in Canada.

Dr S Pal has a Masters in Pharmacy with a PhD in Pharmacology. Been with WHO for nearly 2 decades, and leads the Medicines Safety Programme in WHO, to support pharmacovigilance activities in low and middle income countries and in priority programmes such as HIV, TB, malaria. WHO representative in platforms such as ICH, CIOMS, ICMRA, and a Deputy Board Member of the Uppsala Monitoring Centre, Sweden.

Dr. Keith Wonnacott has 20 years of regulatory experience in the field of cell and gene therapies. He joined Pfizer as an Executive Director of Regulatory Affairs in their Rare Diseases Unit in 2017. At Pfizer, Dr. Wonnacott has a combined role working on regulatory strategy and regulatory policy for gene therapy products. He is active in many professional societies and trade associations and is a recognized expert on regulatory issues related to cell and gene therapies. Dr. Wonnacott made the move to Pfizer after spending the previous 3 years with Novartis Pharmaceuticals as the US regCMC lead for Kymriah. Prior to Novartis, He spent 13 years at FDA, most of which were as the Branch Chief of the Cellular Therapies Branch in CBER.

Dr Houda est directrice de l’inspection pharmaceutique au ministère de la santé de Tunisie. Docteur en Pharmacie depuis 1994. Titulaire du Diplôme d’Etudes Supérieures Spécialisées en Pharmacie Industrielle (DESS).

Doctor at the National Centre of Phamacovigilance of Tunisia Professor of Pharmacology at the Faculty of Medicine of Tunis Member of the Technical Committee for Immunization of Tunisia Head of Allergy Unit at the National Centre of Phamacovigilance of Tunisia

Neil McAuslane is Director of the Centre for Innovation in Regulatory Science (CIRS, previously CMR International) and works in the area of regulatory and HTA strategy and R&D performance. Prior to joining CMR International in 1988, Neil completed his PhD degree in Clinical Pharmacology from the University of Edinburgh and an MSc from Surrey University in Toxicology.

Virginia (Ginny) has worked in industry and academia throughout her career, combining interests in science policy research and innovation performance within and across organizations. She joined MSD in 2017 to lead regulatory policy efforts ex-US for innovation that leads to better treatment for patients globally. Since 2020 this scope has expanded, as Ginny now leads the talented and experienced Global Regulatory Policy and Intelligence team for MSD. Her work has regularly focused on policy shocks that challenge innovation and access to novel therapies for patients, including global and industry-wide policy work on BREXIT, COVID-19 and now the R&D impacts of the Inflation Reduction Act.

Imane is Head of Quality Assurance service for Medicines Assessment at the National Laboratory of Medicines Control of the Directorate of Medicines and Pharmacy (DMP)- Ministry of Health of Morocco. She has an experience of 23 years at the Directorate of Medicines and Pharmacy and she is pharmacist inspector; performed the various inspection of the pharmaceutical structures regarding the Moroccan regulation.Imane has a university degree in biomedical research from the Faculty of Medicine and Pharmacy in the Mohammed V University of Rabat and she is Doctor of Pharmacy from University Granada in Spain.

A doctor graduated from the University of Algiers, holding a Diploma of Advanced Studies from the Faculty of Medicine of Paris (France), a university degree in pharmacovigilance from the university Claude Bernard of Lyon and a doctoral thesis in clinical pharmacology at the Faculty of Medicine of Besançon. She took part in the creation of the CNPM with its founder Professor A Helali in 1998. Since 2016, she has introduced the concept of Phytovigilance, Réactovigilance, Cosmetovigilance, in addition to the vigilance of the drug, the medical device and the vaccine already established. Teacher at the Faculty of Medicine of Algiers. Editor of the independent Medical journal "la Revue Prescrire" since 2007.

Hanane currently works in Directorate of drugs and Pharmacy (DMP) as pharmacist inspector in medical devices department in which she assess and evaluate new introduced medical devices in the country. Ten years of experience spent in Pharmacy, hospitals and service of pharmaceutical products registration. Hanane has a Doctorate in Pharmacy from Faculty of Medicine and Pharmacy of Rabat Morocco, she’s certified in Bioavailability and bioequivalence Studies and she has a diploma in clinical pharmacy, both degrees awarded from the University Mohammed V of Rabat-Morocco.

Rodrigo Palacios is an Executive Director in Regulatory Policy at Roche. He is responsible for advancing global policy on data and technology in the regulatory domain. These topics include Cloud Submissions, Data Standardisation (e.g. IDMP), structured data submissions, eCTD and Regulatory Information Management. Rodrigo represents Roche in EFPIA and PhRMA Regulatory Technology expert groups and acts as PhRMA's deputy topic lead in the ICH M4Q R2 Expert Working Group. He has over 25 years of experience in data and technology strategy, Information Technology management, software development and consulting.

Gracy holds a Ph.D. in Molecular Oncology from King’s College Hospital, an M.Sc. in Biomedical Research from King’s College. She did her postdoctoral training at Oxford (UK) and at MIT (USA). Gracy brings broad experience in clinical research, medical affairs and health outcomes within the pharmaceutical industry. She currently works as a Regulatory Policy Lead at Roche Pharmaceuticals, focusing on RWD Policy.

Peter Pitts is President and co-founder of the Center for Medicine in the Public Interest. Prior to founding CMPI, Pitts was a Senior Fellow for healthcare studies at the Pacific Research Institute. Peter was FDA’s Associate Commissioner for External Relations, serving as senior communications and policy adviser to the Commissioner. He supervised FDA's Office of Public Affairs, Office of the Ombudsman, Office of Special Health Issues, Office of Executive Secretariat, and Advisory Committee Oversight and Management. He served on the agency’s obesity working group and counterfeit drug taskforce.